In a review (May 2021) of the adverse reactions associated with nivolumab and ipilimumab, respectively, Health Canada concluded that there may be a link between nivolumab used alone or in combination with ipilimumab and the risks of autoimmune hemolytic anemia, aplastic anemia, cytokine release syndrome and tumor lysis syndrome.
The Canadian product safety information (Canadian Product Monograph) for nivolumab has been updated to include a warning for the risk of autoimmune hemolytic anemia. Health Canada is working with the manufacturer of nivolumab to also include the risks of aplastic anemia, cytokine release syndrome, and tumor lysis syndrome in the Canadian Product Monograph (CPM).
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- TRADE NAME: Opdivo (Bristol-Myers Squibb)
- INDICATIONS: Metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy; unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor; advanced renal cell carcinoma with prior anti-angiogenic therapy; Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin; head and neck cancer; colon cancer; liver cancer
- CLASS: Antineoplastic / anticancer agent (see also Immune checkpoint inhibitor), Biologic, Immune checkpoint inhibitor (incl. programmed death receptor-1 (PD-1) inhibitor), Monoclonal antibody
- HALF-LIFE: 27 days
- FDA APPROVAL DATE: 03/04/2015
- CLINICALLY IMPORTANT, POTENTIALLY HAZARDOUS INTERACTIONS WITH:
None known - PREGNANCY: Can cause fetal harm
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Click on the DRUG REVIEW ARTICLE tab (above) to see a review of nivolumab in the Taylor & Francis journal Expert Opinion on Drug Safety.
(Note that non-subscribers to the journal will only be able to see an abstract of the article.)
Page last updated 04/04/2025
